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Affolter, Stephan

Ypsomed AG
International Regulatory Changes: Member States - Deal or No Deal: The Impact of the MRA Switzerland – EU on Medtech in Europe

Stephan Affolter
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Akra, Bassil

QUNIQUE GmbH
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Bassil Akra
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Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Bassil Akra
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Arnold-Round, Jane
Combination Products

Jane Arnold-Round
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MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!

Jane Arnold-Round
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Arora, Deepa

Clinexel Life Sciences Private Limited
Working with FDA: Factors for Successful Approval

Deepa Arora
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Arora, Sharry
COVID-19: Implications for the Future of Regulatory
Sharry Arora
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B
Baird, Pat

Philips
Software as a Medical Device: Comparison Between US and EU Approaches

Pat Baird
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Baldwin, Hilary

Caris Life Sciences
Implementing Practices to Comply with the In Vitro Diagnostics Regulation

Hilary Baldwin
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Navigating the Pre-Market Approval Process for FDA

Hilary Baldwin
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Bannick McQuoid, Karen

Bannick LLC
Clinical Evaluation Reports (CERs)

Karen Bannick McQuoid
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Bassett, Richard

NAMSA
Risk Management - Focal Point for Regulatory and Legal Purposes

Richard Bassett
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Bertoli, Maria Mercedes

Self-employee
Orphan Drugs: Challenges and Differences for its Designation in the European Union and the United States of America

Maria Mercedes Bertoli
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Beuzeval, Rod

Meddev Solutions
Meet the Authors: European In Vitro Diagnostic Regulation Guidebook
Rod Beuzeval
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Meet the Authors: European Medical Device Regulation Guidebook
Rod Beuzeval
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Bos, Gert

Qserve Group (Netherlands)
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period

Gert Bos
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Fireside Debate with IVDR Notified Body and Industry Representation

Gert Bos
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Gert Bos
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Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?

Gert Bos
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Bowness, Peter

British Standards Institution
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Peter Bowness
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Buchner, Leonard

Qserve Group
Vigilance and Trend Reporting

Leonard Buchner
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Budashewitz, Philip

U.S. Food and Drug Administration
Working with FDA - Form FDA 1572 (Statement of Investigator) Signature Waivers at Non-US Sites

Philip Budashewitz
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Bundalo, Dragana

PharmaSwiss
Live Q&A: poster presentations 1 - 3
Dragana Bundalo
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Poster Presentation 2: Regulatory Challenges in the Non-EU Countries of the SEE Region

Dragana Bundalo
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C
Celis, Patrick

European Medicines Agency
Regulatory Strategy for Gene Therapy: Challenges and Opportunities

Patrick Celis
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Chaillou, Marc

Schlafender Hase GmbH
The Leading Global Solution For All Your Proofreading Tasks (Sponsored by: Schlafender Hase GmbH)
Marc Chaillou
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Cobbaert, Koen

Philips
Software as a Medical Device

Koen Cobbaert
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Conway, Erica

BSI (London)
In Vitro Diagnostics Regulation (IVDR)

Erica Conway
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Erica Conway
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Cordie-Bancroft, Lena

Qualitas Professional Services, LLC
Developing a Global Unique Device Identification (UDI) Program

Lena Cordie-Bancroft
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Innovators and Regulators: Time to Collaborate

Lena Cordie-Bancroft
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International Regulatory Landscape Changes: Asia & ASEAN Effective Regulatory Strategy & Update in MedTech Product Registration Process

Lena Cordie-Bancroft
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Regulatory Landscape for Medial Device In China

Lena Cordie-Bancroft
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UDI/Labeling

Lena Cordie-Bancroft
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Cuper, Natascha

DARE Medical Certifications
Clinical Evaluation: Clinical Data Versus Non-clinical Data; How to Interpret Article 61.10

Natascha Cuper
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Natascha Cuper
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D
de Bruin, Martin
Hot RA/QA/Clinical Topics (Sponsored by: Qserve)
Martin de Bruin
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Delpozo, Angel

BioKeralty Research Institute
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern

Angel Delpozo
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Di Cioccio, Mark

Team Consulting
Working with FDA - Form FDA 1572 (Statement of Investigator) Signature Waivers at Non-US Sites

Mark Di Cioccio
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Working with FDA - How to Prepare a Well-received IND

Mark Di Cioccio
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Di Rienzo, Giovanni

Qserve Consultancy
Clinical Evaluation Reports (CERs)

Giovanni Di Rienzo
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Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?

Giovanni Di Rienzo
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Dollins, Claudia

Merck Healthcare KGaA
In Vitro Diagnostics Regulation (IVDR)

Claudia Dollins
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Donawa, Maria

Donawa Lifescience
Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies

Maria Donawa
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E
Eglem, Steve

AFMPH (Competent Authority of Belgium)
Clinical Investigation under MDR

Steve Eglem
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F
Farley, Tim

Medidee Services SA
Give Me Data: Challenges and Opportunities of Real-World Evidence

Tim Farley
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Faßhauer, Stefanie

PharmaLex
Changing Pharmaceutical Regulatory Landscape in China and Asia - The Dynamics and Outlook of the ASEAN Regulatory Landscape

Stefanie Faßhauer
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G
Gfoeller, Elizabeth

Med-El
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Elizabeth Gfoeller
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H
Hansen, Joyce

Johnson & Johnson
Innovators and Regulators: Time to Collaborate

Joyce Hansen
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Hansson, Erik

DG for Health and Food Safety (SANTE)
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Erik Hansson
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Hernandez, Monica

Cardinal Health
Live Q&A: poster presentations 4 - 5
Monica Hernandez
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Poster Presentation 5: Can Legislation Evolve Along with Technology? Case Study: Software as Medical Device in Emerging Markets

Monica Hernandez
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Herzog, Dominik

TentaMedix GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Dominik Herzog
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Hidalgo-Simon, Ana

European Medicines Agency
RNA-Based Therapeutics: Opportunities and Challenges

Ana Hidalgo-Simon
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Hoekstra-van den Bosch, Sabina

TUV SUD Product Service GmbH
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period

Sabina Hoekstra-van den Bosch
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Clinical Investigation under MDR

Sabina Hoekstra-van den Bosch
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Clinical Studies in PMCF

Sabina Hoekstra-van den Bosch
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Sabina Hoekstra-van den Bosch
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Hohenbrink, Philipp

Medical Device Safety Service GmbH
In Vitro Diagnostics Regulation (IVDR)

Philipp Hohenbrink
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Hovestadt, Leo

Elekta
Software as a Medical Device

Leo Hovestadt
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Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?

Leo Hovestadt
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Humphreys, Anthony

European Medicines Agency
Supporting Innovation

Anthony Humphreys
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J
Johner, Christian
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Christian Johner
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K
Karrer, Daniela

Donawa Lifescience
Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies

Daniela Karrer
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Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation

Daniela Karrer
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Katta, Jayanth

BSI
Combination Products

Jayanth Katta
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MDR: Lessons Learned

Jayanth Katta
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Jayanth Katta
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Keene, Adrian

NAMSA
Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation

Adrian Keene
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Kennedy, Rachel

LabCorp.
Performance Evaluation Reports - Planning and Preparation in Anticipation of IVDR Requirements

Rachel Kennedy
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Klasen, Eric

Founder of Waypoint Consulting
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Eric Klasen
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Klein, John

NorthCoast Clinical Consulting, LLC
Navigating the Future of Regulatory Affairs - The Future of the Regulatory Affairs Profession

John Klein
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Klompmaker, Sandra

Medidee Services
Give Me Data: Challenges and Opportunities of Real-World Evidence

Sandra Klompmaker
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Kresankova, Katarina

Schlafender Hase GmbH
The Leading Global Solution For All Your Proofreading Tasks (Sponsored by: Schlafender Hase GmbH)
Katarina Kresankova
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Krzeszak, Jason

NAMSA
Working with FDA: Factors for Successful Approval

Jason Krzeszak
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Kuhn, Andreas

BioNTech RNA Pharmaceuticals GmbH
RNA-Based Therapeutics: Opportunities and Challenges

Andreas Kuhn
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L
Laan, Alex

NAMSA
Challenges and Understanding of the Periodic Safety Update Report (PSUR)

Alex Laan
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Lanigan, Mark

World Health Organization
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR

Mark Lanigan
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Larsson, Kristina

European Medicines Agency
Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs

Kristina Larsson
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Lassoff, Peter

Syneos Health
Navigating the Future of Regulatory Affairs - Getting Out More - How Regulatory Affairs Professionals Can Connect with the Shop Floor

Peter Lassoff
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Navigating the Future of Regulatory Affairs - The Future of the Regulatory Affairs Profession

Peter Lassoff
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Lim, Joalin

Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)
International Regulatory Landscape Changes: Asia & ASEAN Effective Regulatory Strategy & Update in MedTech Product Registration Process

Joalin Lim
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Lindner, Christoph

TUV Sud Product Service GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Christoph Lindner
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Liu, Yingying

CSL Behring
Changing Pharmaceutical Regulatory Landscape in China and Asia

Yingying Liu
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Regulatory Landscape for Medial Device In China

Yingying Liu
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Lockwood, John

Pearl Pathways
Working with FDA: How to Get the Most Out of Your FDA Meetings and Interactions

John Lockwood
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Louati, Claudia

US Food and Drug Administration, Europe Office
Regulatory Changes: Biosimilars

Claudia Louati
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M
Maier, Michael

Medidee Services SA
Give Me Data: Challenges and Opportunities of Real-World Evidence

Michael Maier
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The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR

Michael Maier
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Marjan, Dzeparoski

Bionika Pharmaceuticals
Poster Presentation 3: eSubmissions: Regional Moving Towards Global Aspects

Dzeparoski Marjan
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Live Q&A: poster presentations 1 - 3
Dzeparoski Marjan
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Marton, Gabriela

Arriello s.r.o
Regulatory Changes: Biosimilars

Gabriela Marton
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Maxwell, Amanda

Medtech Insight
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period

Amanda Maxwell
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McDermott, Olivia

Olivia McDermott Hayes
Live Q&A: poster presentations 4 - 5
Olivia McDermott
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Poster Presentation 4: The Importance of a Regulatory Qualification and Continuous Professional Development in Career Progression and Advancement

Olivia McDermott
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Meffen, MS, CQA, Tracy

Genevant Sciences
RNA-Based Therapeutics: Opportunities and Challenges

Tracy Meffen, MS, CQA
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Meurant, Robyn

NSF International
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR

Robyn Meurant
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Milobratovic, Irena

Arriello
Regulatory Changes: Biosimilars

Irena Milobratovic
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Moeller, Ludger

Medical Device Safety Service GmbH
MDR Implementation: Economic Operator Requirements

Ludger Moeller
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Morel, Keith

Qserve Group Inc. - ENTERPRISE
Vigilance and Trend Reporting

Keith Morel
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Mortazavi, Charlie

SANOFI
Live Q&A: poster presentations 1 - 3
Charlie Mortazavi
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Live Q&A: poster presentations 4 - 5
Charlie Mortazavi
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MA Lifecycle Management - The Trials and Tribulations of Handling Older Regulatory Applications

Charlie Mortazavi
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MA Lifecycle Management - Towards an Agile Risk-based Variation Regulatory Framework

Charlie Mortazavi
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Mosso, Matteo

Donawa Lifescience
Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies

Matteo Mosso
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N
Ndefo, Yvonne

NSAI
Clinical Studies in PMCF

Yvonne Ndefo
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Neff, Jennifer

bess AG
Orphan Drugs: Challenges and Differences for its Designation in the European Union and the United States of America

Jennifer Neff
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Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs

Jennifer Neff
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Regulatory Changes: Biosimilars

Jennifer Neff
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Nogueira, Diana

Qserve Group Deutschland GmbH
Clinical Evaluation Reports (CERs)

Diana Nogueira
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Nuebling, Micha

Paul-Ehrlich-Institut
In Vitro Diagnostics Regulation (IVDR)

Micha Nuebling
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Micha Nuebling
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O
Omokaro, Stephanie

U.S. Food & Drug Administration
COVID-19: Implications for the Future of Regulatory
Stephanie Omokaro
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Supporting Innovation

Stephanie Omokaro
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P
Padovani, Rima

Medidee Services SA
The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR

Rima Padovani
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Pankhurst, Quentin
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern

Quentin Pankhurst
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Patten, Tom

NSAI
Fireside Debate with IVDR Notified Body and Industry Representation

Tom Patten
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Piriou, Camille

BlueReg
From Product Information to Promotional Material - Promotional Material and National Regulations in EU: How to Successfully Launch Your Product in Different Markets?

Camille Piriou
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Postma, Wiebe

Qserve Group B.V.
Clinical Investigation under MDR

Wiebe Postma
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Clinical Studies in PMCF

Wiebe Postma
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Pradhan, Reeshav

Technical University of Applied Science Luebeck
Live Q&A: poster presentations 1 - 3
Reeshav Pradhan
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Prins, Menno

Eindhoven University of Technology
Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern

Menno Prins
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Purde, Andreas

TÜV SÜD Product Service GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Andreas Purde
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R
Raadsheer, Erik

Align Technology, BV.
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Erik Raadsheer
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Rad, Abtin
- SaMD/Cybersecurity - Regulatory Strategies for Machine Learning/AI and Software as a Medical Device (SaMD)
Abtin Rad
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Reynolds, Chad

Maetrics
MDR Implementation: Economic Operator Requirements

Chad Reynolds
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Richards, Simon

Abbott Rapid Diagnostics
Fireside Debate with IVDR Notified Body and Industry Representation

Simon Richards
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In Vitro Diagnostics Regulation (IVDR)

Simon Richards
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Simon Richards
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Ritzhaupt, Armin

European Medicines Agency
Combination Products

Armin Ritzhaupt
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Fireside Debate with IVDR Notified Body and Industry Representation

Armin Ritzhaupt
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Implementing Practices to Comply with the In Vitro Diagnostics Regulation

Armin Ritzhaupt
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Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Armin Ritzhaupt
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Royle, Matt

NAMSA
Impact of Notified Body Representative Technical Documentation Sampling - It Affects Your MDR Compliance Workload

Matt Royle
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S
Satyal, Umesh

Lübeck University of Applied Science, Lübeck, Germany
Live Q&A: poster presentations 1 - 3
Umesh Satyal
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Scanlan, Elizabeth

European Medicines Agency
From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe

Elizabeth Scanlan
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Schmitt, Siegfried

Parexel
Dealing with Regulatory Requirements - Regulatory Challenges Faced Successfully Taking a New Client out of MHRA Compliance Management Team (CMT) Measures (Data Integrity Issues)

Siegfried Schmitt
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Navigating the Future of Regulatory Affairs - Getting Out More - How Regulatory Affairs Professionals Can Connect with the Shop Floor

Siegfried Schmitt
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Supporting Innovation

Siegfried Schmitt
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Seevers, Robert

Pearl Pathways
Working with FDA - How to Prepare a Well-received IND

Robert Seevers
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Seibl, Reinhart
UDI/Labeling

Reinhart Seibl
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Senac, Julien
Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?

Julien Senac
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Shortt, Colette
From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe

Colette Shortt
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From Product Information to Promotional Material - Promotional Material and National Regulations in EU: How to Successfully Launch Your Product in Different Markets?

Colette Shortt
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Shrestha, Shristi

Lübeck University of Applied Sciences
Live Q&A: poster presentations 1 - 3
Shristi Shrestha
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Poster Presentation 1: Development of a Digital Tool for Risk Management, Post-Market Surveillance, Clinical Evaluation of Medical Devices

Shristi Shrestha
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Shukla, Mridula

Arcutis Biotherapeutics Inc.
Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs

Mridula Shukla
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Regulatory Strategy for Gene Therapy: Challenges and Opportunities

Mridula Shukla
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Slisz, Mark

Pearl Pathways
MA Lifecycle Management - The Trials and Tribulations of Handling Older Regulatory Applications

Mark Slisz
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Spencer, Sue

Qserve Group (United Kingdom)
Fireside Debate with IVDR Notified Body and Industry Representation

Sue Spencer
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Sproho, Thomas

Chubb
MDR Implementation: Economic Operator Requirements

Thomas Sproho
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Stange, Andreas

TÜV SÜD Japan
Fireside Debate with IVDR Notified Body and Industry Representation

Andreas Stange
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Strobel, Hans

dokspot GmbH, Zurich, Switzerland
UDI/Labeling

Hans Strobel
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Sutch, Jonathan

BSI
Combination Products

Jonathan Sutch
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Sweeney, Fergus
COVID-19: Implications for the Future of Regulatory
Fergus Sweeney
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T
Tabutin, Sophie

W.L. Gore & Associates
MDR: Lessons Learned

Sophie Tabutin
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Thompson, David

Clarity compliance solutions ltd
Dealing with Regulatory Requirements - Regulatory Challenges Faced Successfully Taking a New Client out of MHRA Compliance Management Team (CMT) Measures (Data Integrity Issues)

David Thompson
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Torqui, Aimad

MSD
From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe

Aimad Torqui
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Trautman, Kimberly
Risk Management - Focal Point for Regulatory and Legal Purposes

Kimberly Trautman
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Trivedi, Pallavi

Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Changing Pharmaceutical Regulatory Landscape in China and Asia

Pallavi Trivedi
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Changing Pharmaceutical Regulatory Landscape in China and Asia - The Dynamics and Outlook of the ASEAN Regulatory Landscape

Pallavi Trivedi
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COVID-19: Implications for the Future of Regulatory
Pallavi Trivedi
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V
van Boxtel, Robert

Medical Device Project B.V.
Clinical Evaluation: Clinical Data Versus Non-clinical Data; How to Interpret Article 61.10

Robert van Boxtel
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van Dongen, Jacques

Leiden University Medical Center (LUMC)
IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs

Jacques van Dongen
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Van Hove, Luc

MARACA International bvba
Implementing Practices to Comply with the In Vitro Diagnostics Regulation

Luc Van Hove
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Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern

Luc Van Hove
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What is Sufficient Clinical Evidence for IVDs in Preparation for the IVDR?

Luc Van Hove
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Van Hoven, John

Rocky Mountain Regulatory and Quality Partners
Working with FDA: How to Get the Most Out of Your FDA Meetings and Interactions

John Van Hoven
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van Loon, Jan-Paul

Qserve Consultancy BV
MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!

Jan-Paul van Loon
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Van Nerom, Anne

Sciensano
European Union Reference Laboratory for IVD

Anne Van Nerom
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Voelksen, Rainer

VOELKSEN Regulatory Affairs
International Regulatory Changes: Member States - Legal Structure Changes: Pharma, Biotech and Medical Devices Back in DG Health; New German Law (BfArM Receiving Executive Power)

Rainer Voelksen
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Vollebregt, Erik
Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period

Erik Vollebregt
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MDR Implementation: Economic Operator Requirements

Erik Vollebregt
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W
Waesch, Susana

Ypsomed
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Susana Waesch
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Walker, Melissa

Graematter, Inc.
Working with FDA: Factors for Successful Approval

Melissa Walker
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Weijers, Waldo

Medicines Evaluation Board (NL)
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Waldo Weijers
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Wiersma, Anja

mi-CE consultancy
In Vitro Diagnostics Regulation (IVDR)

Anja Wiersma
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IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs

Anja Wiersma
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Witte, Martin

TÜV SÜD Product Service GmbH
Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

Martin Witte
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Z
Ziel, Klaus-Dieter

MEDCERT GmbH, Notified Body Germany
Plenary Session: Global Perspectives on the 2020 Regulatory Landscape

Klaus-Dieter Ziel
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